2024-514570-43-00招募中3 期
TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 169
- 试验地点
- 60
- 主要终点
- Progression free survival: Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to RECIST, or death due to any reasons whichever comes first.
研究概览
简要总结
The primary objective of this study is to compare the progression-free survival (PFS) of tivozanib in combination with nivolumab to tivozanib in subjects with renal cell carcinoma (RCC) who have progressed following 1 or 2 lines of therapy which included an immune checkpoint inhibitor (ICI), assessed by a blinded independent radiological review (IRR).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age, life expectancy ≥ 3 months.
- •Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment.
- •Subjects must have recovered from the adverse events of prior therapy to grade ≤ 1 or baseline.
- •Histologically or cytologically confirmed RCC with a clear cell component.
- •Measurable disease per RECIST criteria Version 1.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •All participants must follow protocol defined contraceptive measures
排除标准
- •Subjects who received: a. A single agent tyrosine kinase inhibitor (TKI) in the first line setting followed by a single agent immune checkpoint inhibitor (ICI) in the second line setting; b. More than 2 prior lines of therapy in the advanced or metastatic setting.
- •History of life-threatening toxicity related to prior immune therapy.
- •Active autoimmune disease as well as those that required discontinuation of prior immuno-oncological (IO) therapy due to immune mediated AEs.
- •Uncontrolled hypertension.
- •More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic setting.
- •Subjects on immune suppressive therapy for organ transplant or subjects with a history of genetic or acquired immune suppression disease such as human immunodeficiency virus (HIV) [Patients with HIV who have CD4+ T-cell counts >350 cells/µL, without a history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections, and are on established antiretroviral therapy which does not include a cytochrome P450 (CYP)3A4 inducer, for at least 4 weeks and have an HIV viral load less than 400 copies/mL, are eligible].
- •History of clinically significant interstitial lung disease or current non-infectious pneumonitis.
结局指标
主要结局
Progression free survival: Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to RECIST, or death due to any reasons whichever comes first.
Progression free survival: Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to RECIST, or death due to any reasons whichever comes first.
次要结局
- Overall Survival: Comparison of the OS of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. OS is defined as the time from the date of randomization to date of death due to any cause.
- Progression free survival: PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to RECIST, or death due to any reasons whichever comes first. PFS as assessed by investigator.
- Objective Response Rate: Comparison of ORR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. ORR is defined as the proportion of subjects with confirmed complete response or confirmed partial response according to RECIST relative to the total population of randomized subjects.
- Duration of Response: Comparison of DoR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. DoR is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause.
- Number of subjects with serious and non-serious adverse events: Assessment of the safety and tolerability of tivozanib in combination with nivolumab compared to tivozanib.
研究者
Chief Medical Officer
Scientific
Aveo Pharmaceuticals Inc.
研究点 (60)
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